check_circleStudy Completed
Contraception
Bayer Identifier:
14701
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study to investigate compliance with the oral contraceptive SH T00186D in a flexible extended regimen supported by a dispenser with a reminder function
Trial purpose
The objective of the study is to evaluate the effect of the dispenser’s buzzer function on compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP) containing oral contraceptive (OC) in a flexible extended regimen when administered for approximately 12 months to healthy female volunteers who request contraception.
Key Participants Requirements
Sex
FemaleAge
18 - 35 YearsTrial summary
Enrollment Goal
508Trial Dates
December 2010 - September 2012Phase
Phase 3Could I Receive a placebo
NoProducts
EE20/DRSP (BAY86-5300)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Klinikum der Johann Wolfgang Goethe Universität Frankfurt | Frankfurt, 60590, Germany |
Completed | Universitätsklinikum Heidelberg | Heidelberg, 69115, Germany |
Completed | Praxis Dr. A. Schwenkhagen-Stodieck | Hamburg, 20357, Germany |
Completed | Praxis Dr. S. Mucha & Dr. G. Schalk | Wuppertal, 42103, Germany |
Completed | Frauenarztpraxis Dipl. med. Michael Stellmacher | Burg, 39288, Germany |
Completed | Frauenarztpraxis Dr. med. Gabriele Weinreich | Magdeburg, 39130, Germany |
Completed | Frauenarztpraxis Dr. Wetzel | Blankenburg, 38889, Germany |
Completed | Praxis Hr. Dr. R. Etzrodt | Gera, 07545, Germany |
Completed | Praxis Fr. Dr. A.Mönch-Hering | Kahla, 07768, Germany |
Completed | A.O.U. Pisana | Pisa, 56126, Italy |
Completed | A.O.U. di Cagliari | Cagliari, 09124, Italy |
Completed | A.O.U. di Bologna - Policlinico S.Orsola-Malpighi | Bologna, 40138, Italy |
Completed | A.O.U. Senese | Siena, 53100, Italy |
Completed | A.O.U. di Modena Policlinico | Modena, 41124, Italy |
Completed | A.O.U. Policlinico - Vittorio Emanuele | Catania, 95123, Italy |
Completed | A.O.U. Policlinico Giaccone | Palermo, 90127, Italy |
Terminated | A.O.U. Seconda Università | Napoli, 80138, Italy |
Completed | IRCCS Fondazione Maugeri Clinica Lavoro e Riabilitazione | Pavia, 27100, Italy |
Completed | A.O. Spedali Civili | Brescia, 25123, Italy |
Completed | Centro de Atención Primaria Ramón Turró-PASSIR | Barcelona, 08019, Spain |
Completed | Centro de Salud Sexual y Reproductiva ELDA | Elda, 03600, Spain |
Completed | Centro de Orientación Sexual para Jóvenes. CS La Victoria | Málaga, 29013, Spain |
Completed | H.Universitario Madrid Montepríncipe | Boadilla del Monte, 28660, Spain |
Completed | Hospital Reina Sofía | Córdoba, 14004, Spain |
Completed | The Health Centre | Bradford-on-Avon, BA15 1DQ, United Kingdom |
Completed | St James's Surgery | Bath, BA1 2SR, United Kingdom |
Completed | The Porch Surgery | Corsham, SN3 9DL, United Kingdom |
Completed | Ely Bridge Medical Centre | Cardiff, CF5 4AD, United Kingdom |
Completed | The Medical Centre | East Horsley, KT24 6QT, United Kingdom |
Completed | Greenwood and Sneinton Family Medical Centre | Nottingham, NG2 4PJ, United Kingdom |
Completed | Avondale Surgery | Chesterfield, S40 4TF, United Kingdom |
Completed | A.O. Sant'Andrea | Roma, 00189, Italy |
Completed | Cabinet Médical - Loiret - Olivet | OLIVET, 45160, France |
Completed | Cabinet Médical - Villersexel - Paris | PARIS, 75007, France |
Completed | Dr. Aliette Siboni-Frisch | Toulouse, 31000, France |
Completed | Cabinet gynecologie | BIARRITZ, 64200, France |
Completed | Dr Cecile Petrequin | Paris, 75018, France |
Completed | CM Ehret-Mentre | STRASBOURG, 67 000, France |
Completed | CM Labouz | STRASBOURG, 67 000, France |
Completed | CM Scheffler | NANCY, 54000, France |
Terminated | CM Dagousset | PARIS, 75 017, France |
Completed | CM Missey Kolb | MARLY LE ROI, 78160, France |
Completed | A.O. Istituti Clinici di Perfezionamento | Milano, 20154, Italy |
Completed | CM Lecocq | PARIS, 75 009, France |
Primary Outcome
- Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release timedate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of delayed and missed pillsdate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Bleeding pattern and cycle control parametersdate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
- Length of the tablet break and the length of the bleeding episode preceding the tablet breakdate_rangeTime Frame:12 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
2Additional Information
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